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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

India Caps Clinical Trial Disability Compensation at $100,000

India has capped compensation for clinical trial volunteers who suffer permanent disability at Rs 66 lakh ($104,000). The figure represents a huge increase over the sums paid out in compensation from 2005 to 2012, but has nonetheless been criticized as being far too low for certain circumstances.

Compensation for permanent disability is now capped at 90% of what can be paid out if a clinical trial participant dies, a stipulation that means all payments will be in the range of $2,800 to $104,000. Trial sponsors must pay compensation regardless of whether they are at fault for the injury, giving India some of the most stringent laws in the world.

However, critics have already questioned the range and how it is calculated. “Going by the official definition, a patient who has lost vision in one eye will be deemed to suffer from 40% disability and entitled to 36% of compensation prescribed in case of death. But if he happens to be a pilot, he will lose his job,” drug regulatory expert CM Gulhati told The Economic Times.

The suitability of the law when it comes to compensation for high earners and for people who require lengthy hospitalizations are two of the main criticisms. Gulhati also questioned why an actuary — the profession that typically determines compensation — was not included on the four-member panel that decided on the methodology.

Even with the caveats, the law still represents a boost for people who have campaigned against what they perceive to be the use of Indians as “guinea pigs” by multinational pharmaceutical companies. Since February 2013, 370 people have died in clinical trials in India. To date, sponsors have paid compensation in 21 cases, DNA India reports.

CDSCO Funding Boost Falls Short of Expectations

The Indian Central Drugs Standard Control Organization (CDSCO) has secured a Rs 900 crore ($142 million) funding boost to strengthen regulatory infrastructure. CDSCO will use the cash to establish a training academy, open new laboratories, modernize existing sites and set up an e-governance mechanism.

Each of the initiatives is intended to address a weakness in the current infrastructure, but anonymous sources within CDSCO and the Indian health ministry have said much more money is needed. “The allocation of Rs 900 crore is the bare minimum that is required for adequate functioning of CDSCO. We had made a proposal to double that sum, which would allow us to train drug inspectors, upgrade and add more laboratories etc,” a senior health ministry official told The Hindu Business Line.

A CDSCO source said the regulator must double the number of inspectors it employs if it is to achieve even a basic level of oversight of manufacturers. State regulators face similar problems. Indian states are set to receive a further $134 million to improve their operations, the weaknesses in which were publicly exposed in the wake of last year’s deaths at a sterilization camp. The All India Drugs Control Officers’ Confederation (AIDCOC) has called on the government to boost regulatory manpower and send state regulators to programs run by their international peers.

China Informs WTO of Plan to Streamline Cosmetics Labels

China’s Food and Drug Administration (CFDA) has told the World Trade Organization (WTO) it plans to revise its requirements for the labeling of cosmetics later this year. CFDA informed WTO’s Committee on Technical Barriers for Trade of its proposal because of the new requirements they place on manufacturers selling cosmetics in China.

The proposals require all labels to be in Chinese, apart from trademarks, foreign company addresses and conventional glossaries, Chemical Watch reports. Manufacturers must also list warnings for certain ingredients found in nail polish, acrylic remover and other flammable products. CFDA will store the new labels in an online system.

CFDA is set to adopt the rules on 1 March 2015 and begin implementing them on 1 July 2015. Companies with products bearing the old label that are already on the market can continue to sell them until 30 June 2016.

Other News:

Pharmaceutical firms in Pakistan have threatened to close their operations after the government pushed ahead with an unpopular pricing policy. The government plans to cap the prices for 318 molecules. Some prices will fall as much as 30%. Further legal action against the government is possible. The Express Tribune

The Indian government has introduced the draft Drug and Cosmetics (Amendment) Bill, 2015 to raise production standards for drugs and medical devices. DNA IndiaI Draft Legislation

China has committed to making it easier for US-based medical device and drug companies to access its markets. The trade agreement aims to speed drug and device approvals. FiercePharmaI More

CFDA has spotted clusters of adverse events among patients who have been treated with citicoline sodium injection. An investigation found the batch of drugs contained visible foreign matter. CFDA Notice (Chinese)

Manufacturers have blamed price controls for an 80% drop in new drug launches in India in recent years. The Economic Times

A CDSCO investigation has led to 12 people accused of being involved with smuggling drugs from China being held in custody. The New Indian Express